Activity monitor to alleviate controlled substance abuse

ABSTRACT

An activity monitor which can be pre-programmed at the factory, the doctors office or the pharmacist, or that can be programmed by the user. The activity monitor is affixed to a medicine bottle or container and activity associated with the bottle or container, such as movement, opening, volume changes, etc. are monitored in view to the schedule. The activity monitor records and allows for the analysis of the recorded data to determine is there is a likelihood of substance abuse.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a non-provisional application filed in the United States PatentOffice under 37 CFR 1.53(b) and 35 U.S.C. 111 as a continuation of theU.S. patent application filed on Mar. 28, 2011, which application is acontinuation-in-part of, and claiming priority to, the U.S.non-provisional application that was filed on Jul. 14, 2009, assignedSer. No. 12/503,065 and bearing the title of “MOTION OR OPENING DECTOR”.

BACKGROUND OF THE INVENTION

One of the cruelest jokes we have ever played on ourselves is the namingof the memory medicine Ginkgo Biloba. Not a smart marketing strategyeither. Nonetheless, the product tends to sell and a reason for thesales may simply be that most of us are plagued and frustrated by memoryfailures. These symptoms manifest itself in trying to remember aperson's name, an item that our spouse asked us to pick up at thegrocery store, or even simply the reason that we got up off of thecouch, walked all the way into another room in the house and then stoodthere wondering why. Most of these situations can be comically laughedoff; however, there are situations where memory failures can be quiteproblematic or even catastrophic.

A perfect example of a situation in which the adverse affect of memorylapses can be realized is in the taking or administering of medication.Depending on the medication and the individual, failure to takemedication can result in severe harm. In view of this, one canappreciate that it can be very important to remember to take oradminister medication, and to do so in a timely manner. Thus, what isneeded in the art is a mechanism that can remind or notify an individualthat he or she must take or administer medication, and even when themedication must be taken or administered.

Another example of a situation in which the adverse affect of memorylapses can be realized is in remembering that you have already receivedor administered a medication. Such memory lapses can result in anoverdose of a medication. In view of this, one can appreciate that itwould be advantageous to have a device that keeps track of taken and/oradministered dosages, notifies or alerts an individual attempting totake or administer an overdose and/or takes measures to help preventoverdosing.

Yet again, with disregard to memory elements, there is a high number ofindividuals that engage in taking prescribed medications either legallyor illegally. Most medications that are prescribed to individuals, aswell as animals, are provided in containers, such as pill bottles,bottles of serum, or pill pouches etc. The packaging for medication canconveniently operate as a dosage reminder/control gateway in that theperson taking or administering the medication at a minimum, mustapproach the packaging to obtain the dosage. In view of thischaracteristic, there is a need in the art for a dosage reminder oroverdose preventer mechanism that can be attached to, adhered to orotherwise be associated with the packaging.

Related to these needs in the art there are additional needs in the artwith respect to determining if a container in general has been opened,moved, tampered with, etc., as well as providing historical data aboutsuch activity with the container and providing alerts regarding suchactivity. These needs in the art can arise in a variety of settings, anda few examples include detecting movement or opening of a liquor bottle,detecting opening of a liquor or gun cabinet, detect movement of amoisture testing apparatus, etc.

Therefore, there is a need in the art for a device that can be used todetect when a container, such as a medicine package or otherwise, hasbeen moved, opened or otherwise tampered with, collecting and storinginformation about such activity, and reporting to or alerting a personor system of such activity.

Most individuals take medicines only for the reasons their doctorsprescribe them and generally at the proper times and in the properdosages. But an estimated 20 percent of people in the United States haveused prescription drugs for nonmedical reasons. This type of usage isreferred to as prescription drug abuse. Prescription drug abuse meanstaking a prescription medication that is not prescribed for you, ortaking it for reasons or in dosages other than as prescribed. Abuse ofprescription drugs can produce serious health effects, includingaddiction. Commonly abused classes of prescription medications includeopiods (for pain), central nervous system depressants (for anxiety andsleep disorders), and stimulants (for ADHD and narcolepsy). Opioidsinclude hydrocodone (Vicodin®), oxycodone (OxyContin®), propoxyphene(Darvon®), hydromorphone (Dilaudid®), meperidine (Demerol®), anddiphenoxylate (Lomotil®). Central nervous system depressants includebarbiturates such as pentobarbital sodium (Nembutal®), andbenzodiazepines such as diazepam (Valium®) and alprazolam (Xanax®).Stimulants include dextroamphetamine (Dexedrine®), methylphenidate(Ritalin® and Concerta®), and amphetamines (Adderall®).

Prescription drug abuse is a serious and growing problem. Experts differon the reasons as to why prescription drug abuse is increasing. But,there are likely multiple factors that are resulting in this trend.

One such factor may be the misperceptions about the safety of takingthese prescription drugs. Because these medications are prescribed bydoctors, many assume that they are safe to take under any circumstances.This is not the case: prescription drugs act directly or indirectly onthe same brain systems affected by illicit drugs; thus their abusecarries substantial addiction liability and can lead to a variety ofother adverse health effects.

Another factor may be due to increasing environmental availability.Between 1991 and 2009, prescriptions for stimulants increased from 5million to nearly 40 million, an 8-fold increase, and opioid analgesicsincreased from about 45 million to approximately 180 million, more thana 4-fold increase. Doctors are prescribing more drugs for more healthproblems than ever before. Online pharmacies make it easy to getprescription drugs without a prescription, even for youngsters.

Further, there are varied motivations for the abuse of theseprescription drugs.

Underlying reasons include: to get high; to counter anxiety, pain, orsleep problems; or to enhance cognition (although they may, in fact,impair certain types of cognitive performance).

According to the NIDA website, in 2008, 15.2 million Americans age 12and older had taken a prescription pain reliever, tranquilizer,stimulant, or sedative for nonmedical purposes at least once in the yearprior to being surveyed. Source: National Survey on Drug Use and Health(Substance Abuse and Mental Health Administration Web Site). TheNIDA-funded 2008 Monitoring the Future Study showed that 2.9% of 8thgraders, 6.7% of 10th graders, and 9.7% of 12th graders had abusedVicodin and 2.1% of 8th graders, 3.6% of 10th graders, and 4.7% of 12thgraders had abused OxyContin for nonmedical purposes at least once inthe year prior to being surveyed. Source: Monitoring the Future(University of Michigan Web Site)

In 2009, approximately 7.0 million persons reported past monthnon-medical use of psychotherapeutic drugs (2.8 percent of the U.S.population). This class of drugs is broadly described as those targetingthe central nervous system, including drugs used to treat psychiatricdisorders (NSDUH, 2009).

Among adolescents, prescription and over-the-counter medications accountfor most of the frequently abused drugs, following marijuana (excludingtobacco and alcohol). Nearly 1 in 12 high school seniors reportednonmedical use of Vicodin; 1 in 20 reported abuse of OxyContin. Overall,1 in 5 teenagers abuse prescription drugs. When asked how prescriptionnarcotics were obtained for nonmedical use, 59% of 12th graders saidthey were given to them by a friend or relative. The number obtainingthem over the internet was negligible.

Thus, there is a need in the art for a solution that can help detectprescription drug abuse and provide information to experts that can beused to identify abuse, report abuse and control abuse.

Today, it is common place to see employers requiring a substance abusescreening as a requirement for employment. Some states, such as Kentuckyfor example, are taking action with regards to individuals receivingpublic assistance. Representative Lonnie Napier from Lancaster has fileda bill for the 2011 session that would require drug and substancescreening for any adults in Kentucky receiving public assistance,including food stamps and state medical assistance. Napier says it isessential to require anyone receiving government assistance to submit totesting. The random testing through the Cabinet for Health and FamilyServices would be a prerequisite to an individual being declaredeligible for public assistance, but it would allow for exceptions if theindividual has a prescription for a controlled substance.

Thus, there is a need in the art for a system, device or method that canbe used to provide information to employers and government officialsregarding an individual's use of prescription drugs.

BRIEF SUMMARY OF THE INVENTION

In a broad sense, the disclosure presents an activity monitor that canbe attached, affixed or integrated into a variety of devices, such as tothe existing packaging of consumer goods that otherwise would not havesuch capability, and provide monitoring, alerting and/or reportingactivity associated with the device. In one embodiment, the activitymonitor operates as a medicine reminder. This embodiment includes aschedule which can be pre-programmed at the factory, the doctor's officeor the pharmacist, can be programmed by the user, or simply beprogrammed automatically by learning the behavior of the user. Theactivity monitor is then affixed to the medicine bottle and activityassociated with the bottle, such as movement, opening, volume changes,etc. are monitored in view to the schedule. If the schedule indicatesthat a dose of medicine should be taken at a particular time, but themonitored activity does not determine that the medicine has been taken,an alert signal will be issued to alert the user that it is time to takethe medicine. In addition, if the monitored activity indicates that themedicine bottle has been opened prior to a scheduled time, then a tamperalert can be triggered.

In another embodiment, the activity monitor operates only as a tamperdetector. In this embodiment, the activity monitor is attached to adevice or container and then started. Any movement or activityassociated with the device or container is analyzed and/or recorded andmay result in triggering a tamper alarm. In some embodiments, the tamperdetector may define windows of time during which activity is permittedto occur and during which activity is not permitted to occur. Activityoccurring during a permitted window will not trigger a tamper alarm.

In one embodiment the activity monitor can be used by insurancecompanies to help alleviate the abuse of controlled substances. In suchan embodiment, the insurer (which may be individuals or a processingsystem operating and operated on behalf of the insurer) may offer adiscount for the controlled substance if the insured individual agreesto receive the prescription in an activity monitored container or toemploy the use of an activity monitor. For such insured individuals, thecontrolled substance, administered in accordance with the prescriptionrequirements, is provided to the insured along with an activity monitor.The substance may be within a container that includes an integralactivity monitor or, along with an activity monitor that can be attachedor coupled to a container housing the substance. The activity monitorthen records activity events related to the dispensing of the controlledsubstance, such as container openings, closings, timing of events,removal of contents, etc. The insurer then receives the recordedactivity events and then conducts an analysis of the event data. If theevent data indicates that there may have been activity that issuspicious of abuse, then the insurer can take remedial actions, such asraising the premium for the insured, refusing further payment forsubscriptions, requiring the insured to seek professional counseling,etc.

In some embodiments, the container and activity monitor may include alock-out mechanism. In such embodiments, the controlled substance isplaced within the container for shipment and, when the container isclosed, the lock-out mechanism is triggered to force the container intoa lock-out state in which the contents cannot be accessed. The insurerthen receives a request to reset the lock-out mechanism from an insuredindividual that has received the activity monitored container with thecontrolled substance. In response to the request, possibly after theinsured is authenticated and verified, the insurer resets the lock-outmechanism such that the insured individual can access the controlledsubstance.

Another embodiment includes method for detecting suspected abuse ofcontrolled substances. This embodiment operates by a pharmacy receivinga prescription for a controlled substance. The pharmacy provides thefilled prescription to an individual in an activity monitored container.The activity monitored container monitors activity of the activitymonitored container related to opening of the container and removal ofsubstance and records activity events and associated time stamps into amemory element. After a period of time, such as a 30 day prescriptionperiod or the like, the pharmacy receives the activity monitoredcontainer from the individual. The pharmacy then accesses data storedwithin the activity monitor and analyzes the retrieved recordedactivity. This activity can then be reported to a third party such as aninsurance provider of the individual, the guardian of the individual,law enforcement authorities, the individual's doctor, etc.

In addition or in lieu of such reporting, the pharmacy may deny thefulfillment of a refill request if the recorded activity indicatessuspicious behavior or provide a refill if the activity indicates normalbehavior.

In another scenario, a physician may be required to issue the monitoringdevice with all or certain prescriptions or for certain patients. Whenthe doctor receives the activity monitor from the patient, he or she candetermine if there has been any misuse. If any misuse is detected, thedoctor may be required to conduct additional screening of the patientbefore he can write another prescription or refill. Advantageously, thisaspect puts the physician in the loop as a key element in helping tocurtail this problem. Further, such a system can limit the ability ofphysicians to abuse the system as they will not be able to freely writeprescriptions without some level of accountability.

These and many other embodiments, as well as various features, aspectsand functions of the various embodiments are more fully presented below.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 is a conceptual depiction of one embodiment of the activitymonitor with FIG. 1A illustrating a top view and FIG. 1B illustrating aside view.

FIG. 2 is a functional block diagram of the components of an exemplaryembodiment of the electronic circuitry 140.

FIG. 3 is a conceptual diagram illustrating one environment suitable forvarious embodiments of the activity monitor.

FIG. 4 is a conceptual diagram illustrating another environment suitablefor various embodiments of the activity monitor.

FIG. 5 is a conceptual diagram illustrating another environment suitablefor various embodiments of the activity monitor.

FIG. 6 is a conceptual diagram illustrating an activity monitor with anadhesive connector.

FIG. 7 is a conceptual diagram illustrating an activity monitor builtinto a cap structure.

FIG. 8 is a conceptual diagram illustrating an alternate location ofattaching the activity monitor to a bottle.

FIG. 9 is a state diagram illustrating the operation of a programmableuser interface in an exemplary embodiment of the activity monitor.

FIG. 10 is a flow diagram illustrating exemplary steps in an embodimentof the learning mode.

FIG. 11 is a flow diagram illustrating typical steps in an exemplaryoperational mode.

FIG. 12 is a block diagram illustrating an exemplary embodiment in whichan activity monitor may operate.

FIG. 13 is a flow diagram illustrating actions that can occur in anexemplary deployment of an activity monitor for detecting prescriptiondrug abuse.

FIG. 14 is a block diagram illustrating various embodiments of aprogramming environment for an activity monitor.

DETAILED DESCRIPTION OF THE DISCLOSURE

The present disclosure, as well as features and aspects thereof, isdirected towards an activity monitor device, apparatus and/or methodthat monitors activity associated with a container. More specifically,one embodiment of the activity monitor utilizes an accelerometer todetect movement of the container and based on the movement, type ofmovement, and timing of the movement, can heuristically determine thetype of activity associated with the movement. In another embodiment ofthe activity monitor, an alert or alarm component may be used to signalor indicate that the container has been moved or opened. In yet anotherembodiment of the activity monitor, signals may be provided based on atiming component to alert a user or device that the container should beaccessed. In other embodiments, devices or mechanisms may be used todetect if a container is opened or if a top or cap has been removed froma container (i.e., a pill bottle cap). One such method to detect if thecap was actually opened is first by using a motion sensor as previouslydescribed, then a piezo signal is sent to the inside of the bottle. Thetime of sending the signal is monitored as well as the time that thesignal is returned, if at all. If the signal is returned, it isconcluded that the cap or top of the container is closed. However, whenthe cap is actually opened, the piezo signal is not returned thus thecap is identified as being open. This technique can be used inconjunction with or alternative to an accelerometer. Similarly, anothersolution may be as simple as having a circuit/sensor between thecontainer (bottle) and the to (cap). In this embodiment, when thecircuit is broken the cap is determined to have been removed. It will beappreciated that the activity monitor presented in this disclosure maybe used in a variety of settings and environments, and may be used for avariety of purposes. Specific examples are illustrated and describedwithin the disclosure to provide a general, overall and specificunderstanding of the various aspects, functions, operations andcapabilities of the activity monitor but, such specific examples areprovided as non-limiting examples.

One specific example in which an embodiment of the activity monitor maybe utilized in within the context of a medicine bottle is activitymonitor. In this example, the activity monitor can operate as a medicinereminder to: (a) signal a user that it is time to take or administer thespecific prescription medication, vitamin, over the counter medication,herb etc. (collectively referred to as medicine) that is stored in thebottle, (b) alert or indicate to the user that the medicine has alreadybeen taken and that no additional dosages are due at the present time,(c) assist the user in finding the medicine bottle, and/or (d) alert orindicate to the user, a doctor, a pharmacists, court, probation officer,12-step recovery sponsor, etc. that someone has moved or opened thebottle at an inappropriate time.

Further elaborating on activity monitor for a medicine bottle, oneembodiment may include a small device that can be attached to the top orcap of the medicine bottle. When the cap on the monitored medicinebottle has not been opened at a scheduled time the activity monitorenters a “reminder alert” state indicating that the content in themedicine bottle has not been take at its scheduled time or within ascheduled window of time. Additionally, the activity monitor can alertthe user if the container has been improperly tampered with by someonethat the content is not intended for (e.g. teenage kids in thehousehold) and signals this to the user by entering a “tamper alert”state. Further, the activity monitor can provide a higher-level ofservice by recording and providing or sending the time and the dosagetaken of a medication to a central system. This information, along withother information that can be collected by other health monitoringdevices (such as that manufactured by Dexcom) attached to the body canbe pertinent information to provide a more real-time evaluation of theperformance and impact that a medication is having on a patient, ratherthan having to make a 2 month follow-up visit.

Turning now to the figures in which several embodiments of the activitymonitor are presented and common elements are represented with commonlabels, the various elements of the embodiments are presented in moredetail.

FIG. 1 is a conceptual depiction of one embodiment of the activitymonitor with FIG. 1A illustrating a top view and FIG. 1B illustrating aside view. The activity monitor 100 includes a case 110. Positioned onthe top of the case 110 are four buttons 120 (A, B, C and D) and analert element 130. The activity monitor 100 includes electroniccircuitry and/or software, including an accelerometer and a batterypower source 140 (shown in dotted lines as they are embedded within thedevice). The electronic circuitry interfaces to the four buttons oractuators 120, the accelerometer and the alert element 130.

FIG. 2 is a functional block diagram of the components of an exemplaryembodiment of the electronic circuitry 140. It will be appreciated thatnot all of the components illustrated in FIG. 2 are required in allembodiments of the activity monitor but, each of the components arepresented and described in conjunction with FIG. 2 to provide a completeand overall understanding of the components. The electronic circuitrycan include a general computing platform 140 illustrated as including aprocessor/memory device 204 that may be integrated with each other or,communicatively connected over a bus or similar interface 206. Theprocessor 204 can be a variety of processor types includingmicroprocessors, micro-controllers, programmable arrays, custom IC'setc. and may also include single or multiple processors with or withoutaccelerators or the like. The memory element of 204 may include avariety of structures, including but not limited to RAM, ROM, magneticmedia, optical media, bubble memory, FLASH memory, EPROM, EEPROM, etc.The processor, or other components may also provide components such as areal-time clock, analog to digital convertors, digital to analogconvertors, etc. The processor 204 also interfaces to a variety ofelements including a control interface 202, a display adapter 208, audioadapter 210, an accelerometer 212 and network/device interface 214. Thecontrol interface 202 provides an interface to external controls 120,such as sensor, actuators or the like. The display adapter 208 can beused to drive a variety of alert elements 130, such as display devicesincluding an LED display, LCD display, one or more LEDs or other displaydevices. The audio adapter 210 interfaces to and drives another alertelement 130′, such as a speaker or speaker system, buzzer, bell, etc.The network/device interface 214 may interface to a variety of devices(not shown) such as a keyboard, a mouse, a pin pad, and audio activatedevice, a PS3 or other game controller, as well as a variety of the manyother available input and output devices or, another computer orprocessing device 226. The network/device interface 214 can also be usedto interface the computing platform 140 to other devices through anetwork 220. The network may be a local network, a wide area network,wireless network, a global network such as the Internet, or any of avariety of other configurations including hybrids, etc. Thenetwork/device interface 214 may be a wired interface or a wirelessinterface. The computing platform 140 is shown as interfacing to aserver 222 and a third party system 224 through the network 220. Abattery or power source 228 provides power for the computing platform140.

In some embodiments the activity monitor may interact with otheractivity monitors or devices through a zigbee type network architecture.In such an embodiment, the activity monitors can gain intelligence bydetecting, receiving and learning other activities or other drugs,medications or substances that were also taken, and at what time (e.g.other vitamins with certain food, this drug with this food, etc.) andthen interface with the other devices to provide recommendations,warnings or instructions about any potential overdoses, druginteractions, etc.

FIG. 3 is a conceptual diagram illustrating one environment suitable forvarious embodiments of the activity monitor. In this embodiment, theactivity monitor 100 is shown as being attached or affixed to a medicinebottle 300 containing medicine to be administered. The activity monitor100 is attached to the top cap of the medicine bottle using any of avariety of techniques, including gluing, adhesive tape, snaps or similarrigid connectors, a screw, tabs, etc. One embodiment of the activitymonitor 100 includes a pre-attached adhesive tape component with aprotective cover. In this embodiment, to attach the activity monitor 100to the medicine bottle 300, the adhesive protector is simply removed andthe tacky surface is pressed against the medicine bottle top or cap.From this point, the activity monitor 100 is then ready to be programmedor activate to schedule and/or monitor use of the content in thecontainer.

FIG. 4 is a conceptual diagram illustrating another environment suitablefor various embodiments of the activity monitor. In this embodiment, theactivity monitor 100 is shown as being attached, affixed or integratedinto a cork or stopper for a bottle, such as a liquor bottle, medicinebottle or any other type bottle 400. In this embodiment, the activitymonitor 100 can come with the bottle 400 or sold separately and useafter the bottle is initially opened. Once the stopper with the activitymonitor 100 is inserted into the bottle, the bottle can then bemonitored.

FIG. 5 is a conceptual diagram illustrating another environment suitablefor various embodiments of the activity monitor. In this embodiment, theactivity monitor 100 is shown as being attached, affixed or integratedinto a screw-on bottle cap 510, such as a liquor bottle, medicine bottleor any other type bottle 500. In this embodiment, the activity monitor100 can come with the bottle 500 or sold separately and use after thebottle is initially opened. Once the stopper with the activity monitor100 is attached to the cap and the cap is placed onto the bottle, thebottle can then be monitored.

FIG. 6 is a conceptual diagram illustrating an activity monitor with anadhesive connector. In this embodiment, underside of the activitymonitor 100 includes an adhesive tape, such as a double sided tape 600that is attached to the underside of the activity monitor 100. Theopposing side of the adhesive tape is typically covered by a plasticcoating or shield to prevent the adhesive from inadvertently beingattached to a surface or gathering debris. Various other attachmentmechanisms may also be used including Velcro or any loop and hooktechnique as well as similar structures. When the activity monitor 100is being put to use, the plastic cover can be removed and the activitymonitor 100 can be attached to the surface of the container or object tobe monitored.

FIG. 7 is a conceptual diagram illustrating an activity monitor builtinto a cap structure.

In this embodiment, the activity monitor 100 is integrated into a cap700 that can be attached to various bottles compatible with the givencap size. As is typical for a bottle cap, ridges 710 may be included onthe surface of the cap to facilitate removal and placement.

FIG. 8 is a conceptual diagram illustrating an alternate location ofattaching the activity monitor to a bottle.

Thus, it will be appreciated that the activity monitor may come in awide variety of shapes, sizes, forms, configurations etc., and theabove-presented embodiments have been provided as non-limiting examples.

Operation of the Activity Monitor

The operation of the activity monitor will be described in threefunctional stages to facilitate a better understanding. However, itshould be appreciated that the functional stages can be mutuallyexclusive of each other or, in some embodiments two or more stages maycoexist on a single activity monitor.

The three stages include: (1) programming; (2) operational; and (3)reporting.

Programming Stage. The programming stage involves the setting up of theactivity monitor to perform a desired function. The activity monitor canbe provided as a pre-programmed device with fixed, non-changeablesettings or, the activity monitor can include a user interface forchanging, modifying and programming the operation of the activitymonitor. In the former embodiment, the programming stage of the activitymonitor occurs during factory construction or, may simply be a defaultdue to memory and/or hardware configurations of the activity monitor. Inthe latter embodiment, the activity monitor includes a user interfacethat allows the user to program, modify or configure the operation ofthe activity monitor.

The programming of the activity monitor configures the activity monitorfor a specific application or use. In one embodiment, the activitymonitor is set at factory fabrication to include one or more operationalconfigurations. Thus, the activity monitor can be fabricated fordifferent and specific applications. In other embodiments, generalpurpose activity monitors that include several pre-programmed featurescan be configured at fabrication. In yet other embodiments, the activitymonitor may include configurable features and operations that can beselected and/or adjusted after fabrication, either at the factory or bya distributor, seller, OEM, or user of the activity monitor.

For programmable embodiments, the activity monitor will include aninterface for programming the activity monitor, selecting features ofthe activity monitor, or setting parameters to adjust the operation ofone or more features of the activity monitor. The programming interfacemay range from a rudimentary interface of a few buttons with audible orled light feedback confirmation to an elaborate, PC based applicationprogram that configures and programs the activity monitor through aport, such as a wireless port (e.g. 802.11, BlueTooth, Zigbee etc) or awired port (e.g USB, FIREWIRE, etc). Furthermore, such an applicationmay allow various software downloads into the activity monitor,including software upgrades, selection and activation of desiredfeatures, parameter settings, etc. Furthermore, programming can occurfrom the system level based on information that was obtained based onthe customers use pattern. Doctors, pharmaceuticals, children,grandparents, etc. can program the device simply by using the device.

Operational Stage. Once the activity monitor is programmed, it is readyto enter operational stage. However, the activity monitor may remaindormant for an extended period of time before it placed into theoperational stage. Also, the reader should understand that even if theoperational stage is entered, the programming stage can be reentered atany time for embodiments that allow reprogramming of the activitymonitor. The operational stage may be entered or triggered in a varietyof fashions. A few non-limiting examples including pushing an “on”button, removing a plastic cover over the battery to allow continuity,removing a cover from a photovoltaic sensor, etc. During the operationalstage, the activity monitor monitors various sensors and makesoperational decisions based on such monitoring. For instance, theactivity monitor may monitor one or more accelerometers, a photovoltaicsensor, biometric sensor, a pressure switch, a magnetic switch, anelectromagnetic switch, RFID detectors, user interface buttons etc.During the operational stage, the activity monitor may also record datainto its internal memory or, transmit date to an external device over awired or wireless interface.

Reporting Stage. Upon completion of the operational stage or, at somepoint after the operational stage is entered, it may be desired toextract data from the activity monitor. this is referred to as thereporting stage. The types of data, frequency of reports, etc. can varygreatly depending on the particular use of the activity monitor. In anycase, in the reporting stage the data that is stored internal to theactivity monitor or, that has been previously extracted is reviewed andany necessary reports that reflect information about the data can begenerated.

Examples of Embodiments

Although the reader will appreciate that a wide variety of uses could beemployed for the activity monitor, a few non-limiting examples areprovided to illustrate the various capabilities, aspects and functionsof various embodiments of the activity monitor.

Medicine Reminder. One feature that may be incorporated into anembodiment of the activity monitor includes the medicine reminderfeature. This feature operates to alert a person or a person caring fora person, patient, animal, etc., that it is time to administer a dosageof the medication contained within a bottle. Thus, the activity monitoris attached to the bottle of interest. The activity monitor isprogrammed to provide an alert at the specific dosage times. Forinstance, if the medicine is to be taken in 4 dosages throughout a 24hour period, the activity monitor can be programmed to provide the alertevery 6 hours. In some embodiments, the exact hours are fixed (such as 6am, 12 pm, 6 pm and 12 am) but, in other embodiments the exact hours canbe adjusted through the user interface, at the factory or based on thespecific times that the activity monitor is used in the learn mode(e.g., 8 am, 12 pm, 5 pm and 11 pm—because this works best with theuser's schedule) configuration. When the activity monitor provides thealert, the activity monitor then begins to monitor the bottle activity.If the activity monitor does not detect that the bottle has been tendedto, such as the accelerometer detecting that the bottle has been movedor opened, or other sensors in the activity monitor detect activity thatindicates the same, then the activity monitor may be programmed toprovide an escalating alert notification (e.g., an increasingly louderalarm). If the activity monitor detects that the bottle has been movedor opened, or that medicine has been removed from the container, thenthe alarm can automatically be reset. In other embodiments, the activitymonitor may include a reset button to silence the alert condition andbegin the next cycle.

Medicine Alarm. Another feature that may be incorporated into anembodiment of the activity monitor includes the medicine alarm. Thefeature operates to help prevent over dosages of a medication. Forinstance, if this feature is combined with the medicine reminderfeature, once the activity monitor detects that the medication has beentaken, a lock-out timer can be initiated. If the activity monitordetects that the bottle or container has been moved or opened during thelock-out period, an alert can be triggered to notify the user that nodosages are presently due to be administered or taken.

Tamper Detector. Another feature that may be incorporated into anembodiment of the activity monitor includes a tamper detector. As atamper detector, the activity monitor can be affixed or attached to avariety of items or containers. If the activity monitor detects that thedevice or container has been moved, opened, jarred, etc., it can recordsuch information as a data entry and/or provide an alert indicator. Thetamper detector may also include windows of time at which activity wouldbe considered to be a tamper, and windows of time during which activityis permissible. For instance, liquor bottles in a bar would include awindow of permissible activity during working hours but, if the bottleis moved while the bar is closed, this would be considered as a tamper.The tamper detector may be configures such that the entrance of aspecific key sequence or authorization code can be used to silence thealarm or exit the alarm state. If the code is not entered properly, thealarm condition continues. Further, rather than simply sounding analarm, the tamper detector may also include an interface to provideexternal notification (i.e., POTS, Cellular, Internet, etc.).

Closed-loop Medication Monitor. It will be appreciated that theinteraction of medication with an individual can vary depending on awide variety of circumstances and elements. Such circumstances andelements can include the body weight of the individual, the individual'smetabolism, the dietary habits of the individual, the saturation of themedication in the individual, the absorption rate of the medication,etc. For instance, the activity monitor can be integrated into or withother monitors, sensors and devices to provide an overall controlmechanism for the administration of medication. As an example, theactivity monitor operating as a medicine reminder may be programmed toadminister certain dosages of medication at specific times. However, inresponse to feedback from other sources, such feedback being associatedwith one or more of the above-identified circumstances and elements, aswell as others, the dosage amount and periodicity of the dosage can bemodified in real-time. Thus, such an embodiment provides a closed-loopmonitoring system that can help to optimize the administration ofmedications. In addition, the activity monitor, or even multipleactivity monitors may be networked together and in communication withone or more remote, distributed or central systems that monitor theactivity reported by the activity monitor, as well as information anddata obtained from a variety of other sources which may includes, asnon-limiting examples, environmental, cost issues, insurance paymentissues, doctor recommendations, other medical test results, otherprescriptions provided to the user, foods that are purchased or taken bythe user, location of the user (for instance is certain substances arebanned in certain areas), activity of the user etc. All of thisinformation can be provided to such other systems and processed. Forinstance, the system may then be operable to send an alert message to anactivity monitor or some other designated destination, or even send alock signal to the activity monitor which can then mechanically lock thecontainer to prevent further access.

To further facilitate the understanding of the various aspects, featuresand applications of the various embodiments of the activity monitor, afew additional non-limiting examples are provided.

Simplified User Interface. In one embodiment, the activity monitorincludes simplified user interface for programming of the medicinereminder function. In the embodiment illustrated in FIG. 1, the activitymonitor includes 4 buttons. However, it will be appreciated that theactivity monitor can include more or fewer buttons and the 4-buttonconfiguration is provided as a non-limiting example only. In theillustrated embodiment, the medicine reminder operation can be set by auser pressing one of the four buttons and holding it down for a givenperiod of time (i.e., 10 seconds) to select the mode of operationassociated with the button. If the buttons are labeled 1, 2, 3, 4,pressing and holding the button can activate the medicine reminder tosound an alarm for the selected number of dosages, periodically througha 24 hour period beginning at the current time. Thus, if the userpresses and holds the 3 button down for the required period of time, theuser will be notified to take a dose at the current time (or this maysimply be assumed) and then, notified again every 8 hours that anotherdosage is due.

In other embodiments, the activity monitor may include intelligence thatmonitors the activity of the user and adjusts the schedule accordingly.For instance, if the user takes a certain medication regularly, if theactivity monitor detects that the user is always 1 hour late for aparticular dose, then the activity monitor may adjust the dosage time tomore align with the user's schedule. Further, the user may be allowed toprogram the activity monitor to provide alert notifications at specifictimes. Thus, the user can have a schedule that is not exactly aligned ona periodic basis but is within prescribed parameters for the particularmedication. Further, the schedule may be adjusted due to other factorsor data received from other sources. For instance, environmental issues(i.e., atmosphere, temperature, stress levels, sleep quantity/quality,etc) may be used to retard or accelerate the dosage due notice. Forinstance, in the case of a migraine patient, a sudden change isbarometric pressure may trigger an earlier notification to take a drugsuch as Topamax or a Triptan.

Programmable User Interface. FIG. 9 is a state diagram illustrating theoperation of a programmable user interface in an exemplary embodiment ofthe activity monitor. In this embodiment, the activity monitor 100 canbe programmed for multiple alerting times (such as four schedules)within a given period of time, typically a 24 hour period. It should beappreciated that although the present example is described as includingup to four alert times within a 24-hour period, that any number of alerttimes over any period of time could also be utilized. For instance, thealerts could based on a time period of a week, 12 hours, or any othertime period including varying times between dosages.

In the embodiment being described, a new activity monitor is firstresident in the dormant state 902. In the dormant state, the activitymonitor does not have any power being applied to the circuitry. To exitthe dormant state 902, power is applied to the activity monitor.Applying power can be accomplished in a variety of techniques including,but not limited to, moving a switch, installing a battery, removing abattery isolator plastic strip, or the like. Once power is applied tothe activity monitor, the activity monitor transitions to the virginmode 904.

In the virgin mode 904, the activity monitor has power applied to itbut, it has not received any programming information or, has notreceived the necessary programming details for operation.

The embodiment being described includes a learning mode 906 tofacilitate self-programming or assisted programming of the activitymonitor. Once the activity monitor is attached to a cap or container,the initial programming is performed by first placing the activitymonitor into a “learning mode”. In an illustrative embodiment, to enterthe learning mode, an actuation by a user is performed. For example, auser may press and hold a particular button, such as the top or centerbutton 130 for a period of time, such as 10 seconds, to cause atransition to the learning mode 906. However, it will also beappreciated that the activity monitor may automatically transition fromthe virgin mode 904 to the learning mode 906 after being powered up orafter a particular period of time. In addition, some embodiments maytransition from the dormant mode 902 directly to the learning mode 906.

FIG. 10 is a flow diagram illustrating exemplary steps in an embodimentof the learning mode. Once the learning mode 906 has been entered, anindicator can be provided as feedback to the user 1002. For instance, toindicate that the activity monitor is in the learning mode 906, the fourexternal LED's 120 can blink, alternating between red and green. Whenthe activity monitor 100 enters the learning mode 906, it resides inthis mode for a programming period of time, such as 24-hours. During theprogramming period, the activity monitor monitors the use of, andmemorizes/records the use of the container associated with the activitymonitor.

In a typical learning mode 906, a loop can be entered to program one ormore schedules based on activity associated with the container.Initially the activity monitor looks for the detection of activity 1004.The first time that the container is opened, accessed or moved withinthe programming period while learning mode is active, the activitymonitor records the time of the activity and associates the time withthe program for schedule 1. For instance, in a particular embodiment, ifactivity is detected 1004, then the time of the activity is recorded forone of the available schedules (such as the next incrementalschedule(n)) 1006. Prior to accepting the activity as a validprogramming, the activity monitor may conduct an analysis of theactivity 1008. The analysis applies heuristics or rules to verify thatthe activity detected actually constitutes a programming request. Theheuristics may include a variety of rules or criteria. A fewnon-limiting examples include:

-   -   (a) is the activity too proximate to other recent activity    -   (b) did the activity meet a threshold activity level, was it too        short to constitute an opening, was it too long, etc.    -   (c) is the current time an increment of previously stored        schedule times?    -   (d) automatically suggesting activating specific times of use        based on the med type, information received from the doctor and        systems and info from the sleeping patterns, etc.

Once the activity monitor accepts the activity as a programming action,the program schedule is update and an indicator that schedule(n) hasbeen programmed can be provided through indicator(n) 1010. Thus, thetime of the activity may be stored in a memory location associated witha first schedule, with each of the LED's on the activity monitor beingassociated with a schedule as well. After programming the firstschedule, the first LED is changed to represent that the programming forthat schedule has been accepted and is complete. For instance, the LEDmay change from alternating between red and green to being a solidgreen, or simply flashing green. The remaining LED's on the activitymonitor continue blinking to show that learning mode is still active.

The activity monitor then determines if the learning mode should beexited 1012 and if not, processing continues at step 1004. At thispoint, it should be appreciated that if the activity monitor is beingprogrammed for a medication that is only taken once a day, then thereare no further steps necessary and the learning mode can be exited. Atthe end of the programming period, the learning mode will be exited withonly one schedule being programmed. However, the user should be carefulnot to take the medication the following day any sooner than a triggerthreshold from the first administration to ensure that the activitymonitor is not confused as to whether this is a second dosage in thecycle or the beginning of a next cycle. In some embodiments, theactivity monitor may query the user to resolve such a conflict.

In addition, some embodiments may also include an actuation mechanism toexit learning mode. For instance, the same actuation used to enter thelearning mode, or some other actuation, may be used to exit the learningmode. As a specific example, when the learning mode is active, the usermay exit the learning mode by either allowing the programming period toexpire or, by manually exiting the learning mode (i.e., pressing andholding the center button 130 for 10 seconds as a non-limiting example).

For medications or items that are taken multiple times per day or perprogramming period, the user simply takes such content at the necessarytimes as prescribed/desired during the initial programming period whilein the learning mode is active. The activity monitor detects activityassociated with the container and, if it concludes that a dosage hasbeen taken, the activity monitor records the additional scheduled timesof use in the other scheduled time periods. For any schedule period thatis not scheduled after the initial programming period learning mode(e.g. schedule #3 and schedule #4 in an example where the user takesdosages only twice daily) the LED's will be clear indicating that thereis no activity associated with those schedules.

Thus, the learning mode can be exited 1012 in a variety of mannersincluding, but not limited to, the programming period expiring, the useractuating an exit button or the conclusion of programming each of theavailable schedules.

Prior to exiting the learning mode, the activity monitor may perform avalidation step 1041 to ensure that the programming information iscorrect or is logical. The activity monitor can look at theabove-identified heuristics as well as other heuristics to determine ifthe program entries appear to be a valid program. For instance, if threeschedules are entered in 6 hour increments and a fourth schedule isprogrammed two hours from the third schedule, the activity monitor maytrigger a programming alert to the user. Depending on the embodiments ofthe invention, the programming alert may simply flash indicating thatthe programming is invalid and needs to be reprogrammed or, a moreelaborate user interface may be employed to indicate what thequestionable programming entries are and allow the user to remedy oroverride.

After the initial programming period, the activity monitor exits thelearning mode 906 and enters operational mode or monitoring mode 908. Inthe operational mode 908, the activity monitor monitors the activityassociated with the container in view of the program schedules. Byapplying a set of heuristics or rules, the activity monitor makes adetermination as to whether or not compliance with the programmedschedules appears to have occurred or if action needs to be taken. FIG.11 is a flow diagram illustrating typical steps in an exemplaryoperational mode.

Initially, the activity monitor 100 may provide an indicator that theactivity monitor is in operational mode 1102. The operational mode 908indicator can be presented in a variety of manners, such as a constantlyilluminated LED, a flashing sequence of LED's or the any of a variety ofother techniques. Similar to the learning mode 906, the operational mode908 then looks for the detection of activity associated with thecontainer but, the operational monitor loop also looks at the programschedules. In the illustrated embodiment, the activity monitor 100 seeksto detect activity associated with the container 1104. If activity isnot detected the program scheduling is examined to determine if an eventhas been missed 1106. If an event has been missed, an alert indicator isprovided 1108 and the alert mode 910 is entered. As a specific example,if a user fails to remove the cap of a container within a thresholdperiod of time after a scheduled time (i.e., 15 minutes as anon-limiting example), the activity monitor provides an alert indicatorand then enters an alert mode 910. In addition, the LED in the scheduleperiod in which the cap has not been opened will blink RED furtherindicating that the content has not been taken.

If activity is detected 1104, then the activity is analyzed in view ofthe afore-mentioned heuristics and rules, as well as others, in view ofthe program schedules 1110. If the activity is valid and is associatedwith a valid, scheduled event, then a indicator may be provided that theprogrammed event has been satisfied 1114 and processing continues atstep 1104 to monitor additional activity. However, if the detectedactivity is not valid or associated with a valid event, then theactivity monitor may trigger a tamper alert and provide an alertindicator 1108 as it transitions into the alert mode 910. As an example,one embodiment of the activity monitor may by default, monitor the useof the cap during the scheduled times and transition to an alert mode ifthe cap is removed more than 30 minutes prior to a scheduled period. Inone embodiment, the activity monitor, when entering tamper alert mode,may chirp rapidly and loud and flash the LED, indicating that the caphas been removed outside of the scheduled periods of use. In otherembodiments, a silent alarm may be employed so that only the valid userknows that the container has been tampered. In yet other embodiments, asignal may be sent to another device, such as a cellular telephone orpager through any of a variety of transmission techniques, to sound analarm or provide a tamper alert indicator. It will be appreciated that awide variety of alerts can be provided in the various embodiments. A fewnon-limiting examples include pre-recorded phrases, sound clips, ringtones, buzzers, tones, vibrations, pings, or the like.

As previously described, the alert mode may be entered due to a missedscheduled event or due to a tamper event. Other alert modes may also bedefined and employed in other embodiments of the activity monitor. Inthe described embodiment, the alert mode can be reset or exited if thealert was caused by a missed event. However, if the alert was caused bya tamper, the activity monitor cannot be reset or, can only be reset byentering a pass code.

To exit the alert mode, the user must actuate the device. In oneembodiment, the alert mode 910 may be exited simply by opening thecontainer and taking the medicine dosage. In other embodiments, one ormore buttons can be pressed and held for a period of time to cause atransition out of the alert mode 910. Various exit means may also beused if it is desired to have the activity monitor exit to a desiredstate. For instance, the activity monitor may exit to the virgin state904 in response to one actuation, the learning mode 906 in response to asecond actuation and the operational mode 908 in response to a thirdactuation.

If the alert mode 910 was entered due to a tamper event, the user may berequired to not only actuate the activity monitor, but then in responseto a prompt, enter a pass code to allow transition from the alert mode.As an example for the embodiment presented in FIG. 1, a user may berequired to press and hold the center button for 10 seconds to initiatea transfer out of a tamper event triggered alert mode. The activitymonitor may then provide an indicator, such as flashing LED's and/or asound to indicate that the user must provide the pass code. The user maythen enter a sequence of buttons 120 that satisfies the required passcode. It should be appreciated that the pass code may be factory set andprovided to the user along with the activity monitor or, the pass codecan be programmed by the user in virgin mode 904 or the learning mode906. As another example, to exit a tamper alert mode, the user may berequired to remove the cap and place it on the counter for 30 secondsmaking sure it's stationary for at least 30 seconds. Next the cap can bereplaced on the container and then by pressing and holding the centerbutton for a prolonged period of time (i.e., 15 seconds). (In anotherembodiment, an external device may be required to cause the activitymonitor 100 to exit the tamper alert mode. For instance, a key mayphysically be entered into the activity monitor to reset the tamperalarm or, a signal from an external device, such as a cellulartelephone, RFID tag, etc. may be used to reset the tamper alert mode.

One embodiment of the activity monitor is a tamper detector. In thisembodiment, the activity monitor can be used exclusively to monitor theinappropriate or unauthorized use of any bottle with a cap, such asprescription drugs, alcohol, sodas in the fridge for children on specialdiets, etc. To program activity monitor to operate exclusively in atamper alert mode around the clock (i.e. no programmed schedules) theactivity monitor is placed into the learning mode. An indicator is thenprovided to the user, such as the LED's blinking and alternating fromred to green indicating it's in the learning mode. While in the learningmode, the activity monitor may then be set to operate as a tamperdetector only using a variety of techniques. In other embodiments, theactivity monitor may come factory set to only operate as a tamperdetector.

As a non-limiting example, for the above-describe embodiment thatincludes 4 program schedules, a tamper only monitor mode can be invokedby using the following programming sequence:

-   -   (1) attach the activity monitor to the container    -   (2) set the container down in a stable and stationary position        for a threshold period of time, the time of 30 seconds is used        as a non-limiting example throughout this procedure    -   (3) remove the cap and place the cap on the counter for 30        seconds making sure the cap is stationary—after 30 seconds, LED        #1 will turn green    -   (4) place the cap back onto the container and wait 30 additional        seconds making sure the cap and container are stationary    -   (5) open the cap again repeating the process 3 more times by        opening the cap and replacing the cap as described above. Once        programmed in the tamper alert mode, all of the LED's will blink        green 5 times and then they will be clear indicating that the        tamper detection mode has been successfully programmed to        monitor any use of the cap at any time.

At this point, if activity is detected, the activity monitor will enterthe tamper alert mode. It will be appreciated that a variety of othertechniques can be used such as pressing and holding certain buttoncombinations, or entering certain button sequences.

In a computer interface enabled embodiment of the present invention, theactivity monitor can be communicatively coupled to a computer forprogramming. In such an embodiment, a wireless technique or a wiredtechnique may be utilized. An application program may be presented onthe computer to identify the connected activity monitor and provideprogramming instructions and capabilities for the activity monitor. Inaddition, the programmed schedules can be read from the activity monitorfor evaluation, and the historical activity of the activity monitor maybe accessed and analyzed.

In a particular embodiment of the present invention, the activitymonitor may be programmed at a pharmacy at the time medication isdispensed to a customer. Thus, the pharmacist can program the activitymonitor in accordance with the doctor's prescription. Similarly, theactivity monitor can be programmed at the doctor's office and providedto the patient. For example, the activity monitor can be programmedautomatically based on the type of drug and the information receivedfrom the doctor (i.e., which may have been sent provided automaticallyto the pharmacist,) as well as, or pre-provided or presently provideduser preferences.

One aspect that can be incorporated into various embodiments of theactivity monitor is a “buy-now” or “order-now” feature. This featureprovides a button on the activity monitor that can be pressed to triggerand initiate an order for a refill. For example, the activity monitormay be provided with the prescription information stored within itsmemory. Further, the activity monitor may be wireless tethered to anInternet connected device, such as a BLACKBERRY or IPHONE. When the“buy-now” button is pressed, prescription information may be read out ofthe activity monitor and then transmitted to the user's pharmacyrequesting a refill or to the doctor's office requesting a renewal ofthe prescription. Similarly, the activity monitor could be utilized witha variety of consumables and operate to provide such notice to a userwith regards to a need to purchase additional quantity.

Another aspect that can be incorporated into various embodiments is thefeature of sending alert messages to various devices and individuals.For instance, for an elderly person, if an alert condition is detected,a message may be sent to the user's children to notify them to come andcheck on their parent. The messages can be sent in a variety for forms,such as pages, text messages, twitter postings, facebook postings, emailmessages, etc.

In addition, the activity monitor may send alert messages to indicatethat it is time to take a dose of medicine. For instance, the activitymonitor may send a text message, email message, or any other variety ofmessages to a user's device, such as a cellular telephone, PDA, IPHONE,etc. The user is then notified that it is time to take his or hermedication.

Prescription Monitor. Various embodiments of the activity monitor areideal solutions for the issues surrounding prescription drug abuse aspresented in the Background section. This is a serious issue that isgetting much attention in our nations. Imagine what our world would belike today if we still had Marilyn Monroe, Jimmy Hendrix, Elvis Presley,Bruce Lee, Keith Moon, Steve Clark from Def Leppard and MargauxHemingway, as well as many others that have died from the abuse ofprescription drugs. Various embodiments of the activity monitor can beused to detect, record, report and prevent prescription drug abuse.

In general, the activity monitor can be used to detect theadministration of medicine, as well as dosages. Information regardingthe use of a substance can be recorded and stored within an activitymonitor. This information can then be accessed by an authority or someentity to determine if there is a suspicion of abuse related to thesubscription. To further describe this aspect of the activity monitor,various examples are provided.

In one embodiment, when an individual is issued a prescription, theactivity monitor can be included along with the medication. The activitymonitor can be programmed with the particularities of the prescriptions,such as dosages, timing intervals, etc. As the activity of the containeris recorded, the history of the usage is obtained. Each time thecontainer is opened and/or medication is removed (volume changes) cancreate an entry in the history. Each entry may include a time stamp.This history can be compared to the internally stored programminginformation for the particular subscription to determine if themedication is being taken properly or, if there is a suspicion of abuse.

In some embodiments, the activity monitor may be paired with a signaturedevice that must be worn by the individual receiving the prescription.In operation, when the activity monitor detects that the monitoreddevice is open, it will search for a signature by sending a probe orlooking for a signal (i.e. such as the technology employed in an RFIDtag). If the signature device is not detected, then this is anindication that the container was opened by an unauthorized person. Inthe case of a nurse or care provider, multiple signature devices can bedeployed and programmed into the activity monitor. The signature devicecan be fastened to an individual by means of a break-once bracelet thatwould verify that the individual has taken the signature device off. Inother embodiments, the activity monitor may be attached to theindividual similar to a house-arrest anklet, embedded in a microchipunder a person's skin or otherwise.

In other scenarios, any individual adjudicated or identified as anabuser maybe required to wear a signature device. In such scenarios, anycontainer equipped with an activity monitor can probe for any signaturedevices nearby and record the proximate signature devices. The activitymonitor can thus be used to detect and report illicit behavior.

If the activity monitor detects suspicious activity, this informationcan be stored in the activity monitor for future access by others. Forinstance, in one example, a patient can be required to bring theparticular container and activity monitor to the pharmacy when obtaininga refill. During the refill process or prior to approving of the refill,the history information can be read back out of the activity monitor andanalyzed. If the pharmacist determines that there is suspicious activity(i.e., excessive use, irregular use, missed dosages, etc), thepharmacist can approach the patient to review the history and, theprescription can be denied if the patient is not able to provideacceptable explanations as to the suspicious activity. For instance, thepatient may be referred back to his doctor or a specialist to review thehistory and determine what actions, if any, are to be taken.

In another embodiment, the activity monitor may include a wirelesstransmitter that is able to communicate in at least a single directionto a remote server system. As activity is detected by the activitymonitor, this information can be relayed back to the server system forrecordation and analysis.

FIG. 12 is a block diagram illustrating an exemplary embodiment in whichan activity monitor may operate. The activity monitor 1205 is shown asto include a communication module or function 1210. This communicationmodule may support any or any combination of a wide variety ofcommunication capabilities including, as non-limiting examples, wiredUSB interface, RS232, FIREWIRE, any 802.11 variety, optical, cellular,or any other variety of wired, wireless, optical etc. For example theactivity monitor 1205 can communicate information to a local processingunit 1230 (such as a server, computer, etc.) through a wired interface1262. The activity monitor may communicate to the same local processorunit 1230 through a local wireless connection 1264 through wirelessreceiver 1220. The activity monitor 1205 may communicate with a widerrange wireless technology, such as cellular, digital cellular, 3G, 4G,GSM, GPRS, CDPD or the like over path 1268 to a wireless receiver 1250.In addition, the activity monitor may include a GPS receiver forrecording the location at which the detected activity occurred. Thecommunication of the activity monitor 1205 may also be carried forwardto a network 1240, such as the Internet, to provide information to othersystems. In some embodiments, the communication may be onedirection—from the activity monitor out—but, in other embodiments theactivity monitor may also include a receiver for receiving communicatedinformation.

In embodiments that include an 802.11 wireless communication capability,the device can be set up to automatically detect the networks of thepatient's pharmacy and doctor such that if the patient brings theactivity monitor and container within the vicinity of their doctor orpharmacists, the activity monitor data can be automatically downloaded.

In operation, the activity monitor can be programmed when attached to acontainer containing an issued prescription. FIG. 13 is a flow diagramillustrating actions that can occur in an exemplary deployment of anactivity monitor for detecting prescription drug abuse. For instance, asis typical in the industry, a doctor will write a prescription for apatient and the doctor's office either sends the prescription to thepatients pharmacy or the patient hand carries the written prescriptionto the pharmacy. Upon reception and verification of the prescription1302, the pharmacist can program and attach the activity monitor to thecontainer 1304 and provide the fulfilled prescription and activitymonitor equipped dispenser to the patient 1306. When the activitymonitor equipped dispenser is provided to the patient, the monitor isturned on and the activity monitor begins to detect and record activityrelated to the dispenser 1310 1320. It should be noted that thedispenser may be a typical medicine bottle with the activity monitorattached thereto, or the activity monitor may take the form of a cap onthe bottle.

In addition, in some embodiments the activity monitor and the containermaybe integrated elements such that once a substance is placed into thecontainer and the container is closed, the patient cannot gain access tothe contents but through a dispensing function in the bottle. As anon-limiting example, the dispenser may enable the dispensing of onlyone pill at a time by including a mechanical or electro-mechanicalsystem that would allow only one pill to be dispensed. This could beimplemented by having a two walled chamber access in which the chamberis sized such that one dosage of the medication can fit inside thechamber. The dispenser can then be manipulated to ensure that a dosagehas entered into the chamber. For example, if the chamber is in the topof the dispenser, the dispenser can be turned upside down and shaken toget the dosage of medication into the chamber. Once the dosage is loadedinto the chamber, a button can be actuated causing an interior door ofthe chamber to shut and an exterior door of the chamber to open therebyproviding access to the dosage. Thus, such an embodiment can ensure thatonly one dosage of medication is retrieved at each access without havingto monitor the volume as in previously described embodiments. Those ofordinary skill in the art will appreciate that such a dispenser could becreated in many different configurations and employing a variety oftechniques but, the monitored dispenser embodiment is not limited to anyparticular implementation. Rather, any container or dispenser thatprovides the ability to monitor and control the dispensing of themedication to control and detect abuse could be utilized in the variousdisclosed embodiments.

In another embodiment, rather than measuring or controlling volume, theactivity monitor may include strain gauges or weight detectors. Forinstance, the buttons on the activity monitor, or additional actuators,can be placed on a table and used to measure the weight of thecontainer. The change in weight can be used to determine how much of thecontents were removed at each activity occurrence. Thus, after eachaccess, the device may prompt or require the user to place the containeron a flat surface with the sensors facing down. Once the weightmeasurement is taken, the information is stored within the activitymonitor. Failure to allow such a measurement may also be recorded.

The activity monitor can then begin monitoring the container to detectany activity that can be indicative of a dosage of the medication beingtaken 1310 1320. The activity monitor records any detectable events ofthe patient 1320 along with a corresponding time stamp into its memory.It will be appreciated that in addition to a process used to detect andrecord activity to monitor abuse, any of the previously describedfeatures, functions and embodiments may also be included along with thisfeature. For instance, if the dispenser is accessed and/or a dosage isremoved prior to the authorized time, the activity monitor may recordthis in memory as an event, sound an alarm, send a message to thepatient, send a message to the pharmacy, etc. However, the advantage ofthe recorded information is that it can silent observe and recordinformation that can clearly indicate if the medication is being takenas prescribed.

FIG. 14 is a block diagram illustrating various embodiments of aprogramming environment for an activity monitor. In the illustratedenvironment, an activity monitor 1405 includes a communication interface1410. A programming source 1450 interfaces with the activity monitor1405 over a communication channel 1460. It should be appreciated thatthe programming source can be any of a variety of devices such as adedicated device, a webpage accessible via a browser, a point of saleterminal at a pharmacy, a computing device at a doctor's office,probation officer's office, recovery program sponsor's office, etc. Thecommunication channel 1460 can likewise be any of a variety of channelsincluding wireless, optical, RF, Bluetooth, WIFI, etc. In operation, theprogramming source can provide an interface to allow the activitymonitor to be programmed for various forms of operation as presentedthroughout this description.

Today, absent the presently described embodiments, when a patientapproaches the pharmacy at the standard refill time, the pharmacist mustassume that the medication was taken as prescribed. However, with theactivity monitor, the patient can be required to bring the dispenserwith the activity monitor back to the pharmacy for a refill 1330. Therecorded data can then be retrieved and analyzed by the pharmacist orother authorized party 1332). Based on the analysis of the recordeddata, appropriate actions may be taken. For instance, if the recordeddata indicates the medicine has been properly taken, the pharmacist mayrefill the prescription. However, if the recorded data indicates thatthere has been suspicious activity, then the fulfillment of the refillmay be denied or postponed 1334. As a non-limiting example, if therecorded data indicates that the container was only opened a subset ofthe number of authorized times, this can be flagged as suspiciousactivity (i.e., more medication was taken out for each access thanshould have been). Further, if the recorded information indicates thatthe container openings occur too frequently and without sufficient delaybetween accesses, this can also be flagged as suspicious activity. Inaddition, body sensors may also be used in conjunction with the variousembodiments. The body sensors can be used to monitor the presence of themedication within the individual. If the body sensor does not detectthat the medication is actually present in the user, this may flag anabuse. When such suspicious activity is detected, the pharmacist mayrequire the patient to return to his doctor to renew the prescription ortake other counter measures.

It should be appreciated that the activity history stored within theactivity monitor may be access by an external system in a variety ofmanners as previously described. However, in some embodiment, theactivity monitor may include a screen or display. In such embodiments,the activity history may be accessed and displayed on the screen ordisplay. In other embodiments, an external display may be connected tothe device to allow the activity history to be read.

Such embodiments of the activity monitor may also be used for performingdrug screenings by employers, government workers issuing public funds toindividuals, etc. For example, the potential individual may be requiredto bring all prescription medications into office where the screeningwill take place. For the appropriately equipped containers, the screenercan access the data on the activity monitors and determine thelikelihood of substance abuse based on this information.

In some embodiments, the activity recorder of the activity monitor mayallow for patient interaction. For instance, as a non-limiting example,each time the container is opened and/or it is detected that a dosagewas taken, the activity monitor can send an SMS or email to the patientidentify what activity has occurred and when the activity occurred andrequest the patient to confirm receipt, validity and provide furtherinformation regarding the activity point. This feature advantageouslyinvokes a report or notice to the patient that an unauthorized access ofthe medicine container has taken place. Further, the patient can thenprovide a responding email either confirming or denying knowledge of theevent and providing further information related to the event. Forinstance, if the patient opened the wrong bottle and then, the patientrealized that he or she opened the wrong bottle prior to taking a pill,this may trigger an email to the patient. The patient can then explainwhy the container was opened and confirm the current inventory.

In some embodiments, the activity monitor may also include a lockingmechanism. As previously described above with regards to a controlleddispenser, the lock-out mechanism may permanently prevent the patientfrom opening the container and require the use of a dispenser mechanism.In other embodiments, the lock-out may only be activated when suspiciousactivity is detected. For instance, if it is detected that a dosage wastaken too early or too many items were removed, the lockout mechanismmay trigger to prevent further access to the contents. In such anembodiment, the patient may be required to take the container back tothe pharmacy to have the lock-out mechanism reset. At such time, thepatient can be queried regarding the activity. In other embodiments, thelock-out mechanism may be triggered between dosages such that access tothe contents is prevented until within a threshold period of the nextdosage and, re-triggered after the dosage is taken or after anotherthreshold period of time after the scheduled dosage. The lock-outmechanism may also require the entrance of a password, finger print,voice recognition, etc., to reset the lock-out. Thus, in such anembodiment not only is activity monitored, but the contents can only beaccessed by the appropriate party. The lock-out mechanism can beimplemented in a variety of techniques. A non-limiting example of alockout mechanism would be employing an interior locking mechanismsimilar to a DVD case that internally locks down. Such an embodiment canprevent cap rotation and removal until a password or required activityis performed.

In some embodiments, the detection/monitor device may be required by acourt order.

For instance, for an offender, the court may order the individual toutilize monitoring devices for all of their prescription drugs. Theindividual may be required to report periodically for a download of thehistorical use of the monitoring device. If abuse is detected then theindividual may be incarcerated.

It will be appreciated that such protection mechanisms may also giverise to a risk to patient health. For instance, if a patient isprevented from accessing his or her medication, serious harm may occur.As such, a mechanism to override the lock-out feature may be necessary.An override capability may be implemented in a variety of manners. Inone embodiment, any pharmacy or doctor may have access to a “super user”code or override code that would give them access to any container andoverride the lockout mechanism. In another embodiment, the activitymonitor may be equipped with a tone receiver that can detect thereception of a required unlocking tone or tonal sequence and disable thelock-out mechanism once received. For instance, if an emergency arises,the patient may call 911 or another dedicated number that may bepublished on the container, explain the circumstances and once approved,the called party can transmit the tone or tonal sequence over thetelephone line. The patient can hold the bottle next to the speaker ofthe telephone to have the tone or tonal sequence detected.

It will also be appreciated that various mechanisms may be used todetect access to the container. As previously described, one or moreaccelerometers by be used to detect movement, such as the removal of acap. However, other mechanisms may also be employed. For instance, amechanism may be used to detect cap rotation and direction of rotation.Such a detector can be used to detect opening and closing of thecontainer. As an example, the cap may include a magnet and the containerinclude a series of magnets or metallic surfaces, with spaces betweeneach surface. As the cap is rotated, movement of the magnet past theother magnets or metallic surfaces can be detected and thus detect thepresence and direction or rotation. Similar, optical detectors withspaced apart apertures or other mechanisms may also be employed.

Insurance Requirements. The various embodiments of the present inventionmay be provided in conjunction with insurance programs. For instance, aninsurance company may require their customers to have activity monitordispenser issued for all prescriptions or for certain drugs. Theinsurance company may provide premium discounts or prescriptiondiscounts in exchange for the customer agreeing to receive monitoredprescriptions. Further, the information collected may be used to offerfurther discounts to customers with good history or, used to increasethe premiums for customers that consistently show suspicious activity.It will also be appreciated that many insurance companies allow thefulfillment of prescriptions by mail. The various embodiments of theactivity monitor may also be used in these circumstances. For instance,the medications can be delivered with an activity monitor. In anexemplary embodiment, the activity monitor may have a lock-out mechanisminitially triggered and the patient may be required to perform anactivity to have the lock-out mechanism reset. For instance, the patientmay have to call a particular number to obtain a code, receive a tone ortonal sequence, connect the activity monitor to his or her computer andaccess a monitor website that can down load information to and from theactivity monitor over the Internet, program the activity monitor and/orreset the alarm.

In other embodiments, the patient may be issued one or more activitymonitors that must be attached or used in conjunction with receivedmedications. The patient may be trusted to attach the activity monitorto the received medications or, the received medications may bephysically locked down until the activity monitor is attached.

In some embodiments, the activity monitor may simply includeaccelerometer(s) to detect movement. However, in other embodiments theactivity monitor may include more complex technology to measure volumesof material within the container. In such an embodiment, the activitymonitor can effectively notify a user when the dosage taken was toosmall, too large or just right. In addition, this embodiment of theactivity monitor can detect when the contents are getting low andinitiate or alert that it is time to refill the prescription. Forinstance, the activity monitor may include a sensor, such as a depthfinder technology sensor, that can be used to determine the volume ofcontents. When the activity monitor is first installed, the senorconducts an initial volume check. After each subsequent opening, thesensor again checks to content volumes. If an unusual change in volumeis detected, or if no change is detected when a change was expected, andalert can be provided.

The activity monitor can be provided and marketed in a variety ofmanners. For instance, in one embodiment, the activity monitors may bedisposable devices that are thrown away with the empty medicine bottles.In such an embodiment, programming can be simplified as the device willbe used with only one medicine for a limited period of time. In such anembodiment, the activity monitor may be sold by itself, or in groups,such as 4 packs and 6 packs, with the batteries already installed butdisabled by use of a plastic isolating strip that can be removed whendesired for operation. In other embodiments, the activity monitor mayinclude a replaceable or chargeable battery and can be reused andreprogrammed multiple times.

In the description and claims of the present application, each of theverbs, “comprise”, “include” and “have”, and conjugates thereof, areused to indicate that the object or objects of the verb are notnecessarily a complete listing of members, components, elements, orparts of the subject or subjects of the verb.

In this application the words “unit” and “module” are usedinterchangeably. Anything designated as a unit or module may be astand-alone unit or a specialized module. A unit or a module may bemodular or have modular aspects allowing it to be easily removed andreplaced with another similar unit or module. Each unit or module may beany one of, or any combination of, software, hardware, and/or firmware.

The present invention has been described using detailed descriptions ofembodiments thereof that are provided by way of example and are notintended to limit the scope of the invention. The described embodimentscomprise different features, not all of which are required in allembodiments of the invention. Some embodiments of the present inventionutilize only some of the features or possible combinations of thefeatures. Variations of embodiments of the present invention that aredescribed and embodiments of the present invention comprising differentcombinations of features noted in the described embodiments will occurto persons of the art.

It will be appreciated by persons skilled in the art that the presentinvention is not limited by what has been particularly shown anddescribed herein above. Rather the scope of the invention is defined bythe claims that follow.

What is claimed is:
 1. A method for an insurer to help alleviate anabuse of controlled substances by insured individuals that pay a premiumfor insurance to the insurer, the method comprising the actions of: theinsurer offering a discount for controlled substances that aredistributed in conjunction with an activity monitor that is integratedwith a container holding the controlled substances; providing controlledsubstances in the container with the integrated activity monitor, thesubstances being provided in accordance with a valid prescription,wherein the activity monitor records activity events related to thedispensing of the controlled substance; the insurer retrieving therecorded activity events; the insurer analyzing the recorded activityevents; and the insurer adjusting the premium offered to the individualcontinued insurance coverage if the analysis of the recorded activityindicates activity that is commensurate with the abuse.
 2. The method ofclaim 1, wherein the insurer includes a processing system.
 3. The methodof claim 1, wherein the container and integrated activity monitorincludes a lock-out mechanism and, further comprising the actions of:placing the controlled substance within the container; closing thecontainer and activating the activity monitor in a lock-out state;receiving a lock-out reset request from an insured individual that hasreceived the activity monitored container with the controlled substance;and resetting the lock-out mechanism such that the insured individualcan access the controlled substance.
 4. The method of claim 3, whereinthe action of resetting the lock-out mechanism further comprisesreceiving a code sequence that is entered by the insured individual toreset the lock-out mechanism.
 5. The method of claim 3, wherein activitymonitor includes a tone detector and the action of resetting thelock-out mechanism further comprises sending one or more tones over atelephone line to be received by the activity monitor.